A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)

Initiator Pharma

Status and phase: Enrolling; Phase 2

Conditions: Vulvodynia

Treatments: Drug: Pudafensine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07391241

IP2015CS05

Details and patient eligibility

About

The study (IP2015CS05) is a randomised, double-blind, placebo-controlled, 4-way cross-over trial studying the efficacy and safety of single dose administration of pudafensine in vulvodynia (provoked vestibulodynia) patients.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant with vulvodynia (provoked vestibulodynia).

Exclusion criteria

• Women with vulvar pain caused by a specific disorder:

  1. Infectious (e.g. recurrent candidiasis, herpes).
  2. Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders).
  3. Neoplastic (e.g. Paget disease, squamous cell carcinoma).
  4. Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma).
  5. Trauma (e.g. female genital cutting, obstetrical).
  6. Iatrogenic (e.g. postoperative, chemotherapy, radiation).
  7. Hormonal deficiencies (e.g. genitourinary syndrome of menopause (vulvovaginal atrophy), lactational amenorrhea).

• History or current diagnosis of significant pelvic floor dysfunction.

• Co-morbid pelvic pain conditions including pain due to pelvic fractures, pelvic girdle pain or post-partum pelvic pain (to avoid confounding pain outcomes).

• History or current diagnosis of pelvic inflammatory disease.

• History or current diagnosis of endometriosis.

• History or current diagnosis of interstitial cystitis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Dose_1

Experimental group

Description:

Pudafensine

Treatment:

Drug: Pudafensine

Dose_2

Experimental group

Description:

Pudafensine

Treatment:

Drug: Pudafensine

Dose_3

Experimental group

Description:

Pudafensine

Treatment:

Drug: Pudafensine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Pudafensine